k******a 发帖数: 306 | 1 Recruiting company and position brief to candidates 招聘公司 & 职位简介
Pls contact Joyce:d******[email protected] if interest or for more information
Company: A global leading CRO
Location: Shanghai, Pudong District(Nanhui)
Title: Toxicology Study Director III
The statements below reflect the general responsibilities and requirements
of the identified position but may not describe all the work requirements
that may be inherent in the job.
I. Job Summary:
A. General Purpose and Scope:
• Serves as a Study Director, as described in the GLPs. Has
overall responsibility for the technical conduct of a study as well as for
the interpretation, analysis, documentation, and reporting of results.
B. Duties and Responsibilities:
• Coordinates efforts of the study team.
• Develops protocols and ensures that the protocol, including any
changes, is approved and is in compliance with appropriate SOPs, GLPs, and
regulatory agency guidelines.
• Reviews cost estimates to ensure that all protocol/amendment
driven workscope specifications have been included in the price estimation.
• Understands financial status of ongoing studies.
• Monitors progress and status of assigned studies. Ensures that
all experimental data, including observations of unanticipated responses to
the test system, are accurately recorded and verified.
• Directs preparation of reports, ensures compliance with protocol
and regulatory requirements, and submits them to the client.
• Participates or hosts client visits.
• If possible, participate on Six Sigma project team.
• May serve as a mentor to newly hired Study Directors.
• Six Sigma Team Trained.
• Performs other related duties as assigned.
C. Principal Contacts
• Internal
o Study Director Management, Mentor, Study Toxicologists, Clinical
Pathology, Formulations, Large and Small Animal Operations, DLAM, Quality
Assurance, Client Services, Program Management, Report Coordination,
Statistics
• External
o Client Study Monitors, Client Management, Client Quality Assurance
representatives
D. Travel Requirements: Yes
• Typically attend, and present at, one national/international
scientific meeting per year.
• Occasional visits to client facilities.
E. Language Skills Required:
• Excellent English speaking, reading and writing skills, including
technical documents
• Chinese reading, writing and speaking
II. Education/Qualifications:
Required:
• PhD in toxicology or related subject, DVM or equivalent degree.
Experience may be substituted for education.
III. Experience:
Required:
• Three to five years of related experience. Relevant experience
may be substituted for years of related experience.
• Skilled in performing scientific presentations and preparing
scientific publications.
IV. Competencies: Leadership
Required:
• Wins Customer Loyalty Manager
• Leads by Example Manager
• Inspires Others Manager
• Drives Growth Manager
• Builds Talented Teams Manager
• Confronts Constructively Manager
• Gets it Done Manager
V. Working Conditions:
• Mandatory immunizations and screening as required
• May work with potentially hazardous substances
VI. Special Factors:
• Overtime and weekend work as required |
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